Atopic DermatitisPhase 2NCT03011892
A Study to Evaluate the Safety and Efficacy of Ruxolitinib Phosphate Cream Applied Topically to Adults With Atopic Dermatitis
A Phase 2 study testing Ruxolitinib 0.15% Cream QD, Ruxolitinib 0.5% Cream QD and Ruxolitinib 1.5% Cream QD in people with Atopic Dermatitis, run by Incyte Corporation at 52 sites in 2 countries.
Trial summary
The purpose of this study is to establish the efficacy of each strength of ruxolitinib cream once daily (QD) or twice daily (BID) in participants with atopic dermatitis as compared with vehicle cream BID. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Ruxolitinib 0.15% Cream QD, Ruxolitinib 0.5% Cream QD and Ruxolitinib 1.5% Cream QD
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 307 participants
- Where
- 52 sitesin 2 countries
- Study dates
- 9 Jan 2017to 12 Mar 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants diagnosed with atopic dermatitis (AD) as defined by the Hanifin and Rajka criteria.
- Participants with a history of AD for at least 2 years.
- Participants with an Investigator's Global Assessment (IGA) score of 2 to 3 at screening and baseline.
- Participants with body surface area (BSA) of AD involvement, excluding the face and intertriginous areas, of 3% to 20% at screening and baseline.
- Participants who agree to discontinue all agents used to treat AD from screening through the final follow-up visit.
Who cannot join
- Participants with evidence of active acute or chronic infections.
- Use of topical treatments for AD (other than bland emollients) within 2 weeks of baseline.
- Systemic immunosuppressive or immunomodulating drugs (eg, oral or injectable corticosteroids, methotrexate, cyclosporine, mycophenolate mofetil, azathioprine) within 4 weeks or 5 half-lives of baseline (whichever is longer).
- Participants with other dermatologic disease besides AD whose presence or treatments could complicate the assessment of disease (eg, psoriasis).
- Participants with a history of other diseases besides dermatologic disorders (eg, other autoimmune diseases) taking treatments that could complicate assessments.
- Participants with cytopenias at screening, defined as:
Show all 16Show fewer
- Leukocytes < 3.0 × 10^9/L.
- Neutrophils < lower limit of normal.
- Hemoglobin < 10 g/dL.
- Lymphocytes < 0.8 × 10^9/L
- Platelets < 100 × 10^9/L.
- Participants with severely impaired liver function (Child-Pugh Class C) or end-stage renal disease (ESRD) on dialysis or at least 1 of the following:
- Serum creatinine > 1.5 mg/dL.
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 1.5 × upper limit of normal.
- Participants taking potent systemic cytochrome P450 3A4 inhibitors or fluconazole within 2 weeks or 5 half-lives, whichever is longer, before the baseline visit (topical agents with limited systemic availability are permitted).
- Participants who have previously received Janus kinase (JAK) inhibitors, systemic or topical (e.g., ruxolitinib, tofacitinib, baricitinib, filgotinib, lestaurtinib, pacritinib).
Trial locations and contacts
52 sites in 2 countries.
52 sites in 2 countries
United States35 sites
ARLINGTON RESEARCH CENTER, INC, 711 East Lamar Blvd
Arlington, Texas, 76011
DERMRESEARCH INC., 8140 North Mopac Expressway
Austin, Texas, 78759
HASSMAN RESEARCH INSTITUTE, LLC, 175 Cross Keys Road
Berlin, New Jersey, 08009
ACTIVMED PRACTICES & RESEARCH, INC, 138 Conant Street
Beverly, Massachusetts, 01915
DERMATOLOGISTS OF GREATER COLUMBUS, 2359 East Main Street
Bexley, Ohio, 43209
UAB DERMATOLOGY, 2000 6th Avenue South
Birmingham, Alabama, 35233
TUFTS MEDICAL CENTER, 800 Washington Street
Boston, Massachusetts, 02111
BURKE PHARMACEUTICAL RESEARCH, 601 W. Commerce
Bryant, Arkansas, 72022
CHARLOTTESVILLE DERMATOLOGY, 600 Peter Jefferson Parkway
Charlottesville, Virginia, 22911
RAPID MEDICAL RESEARCH, INC, 3619 Park East Drive
Cleveland, Ohio, 44122
J&S STUDIES, INC, 1710 Crescent Pointe Pkwy
College Station, Texas, 77845
HENRY FORD HOSPITAL, 3031 West Grand Blvd
Detroit, Michigan, 48202
ENCINO RESEARCH CENTER, 16133 Ventura Blvd
Encino, California, 91436
DERMATOLOGY CONSULTING SERVICES, PLLC, 2444 North Main Street
High Point, North Carolina, 27262
CENTER FOR CLINICAL STUDIES (CCS), 1401 Binz
Houston, Texas, 77004
SUZANNE BRUCE AND ASSOCIATES, PA, 1900 St. James Place
Houston, Texas, 77056
DERMATOLOGY RESEARCH ASSOCIATES,8930 South Sepulveda Blvd
Los Angeles, California, 90045
DERMRESEARCH, 1169 Eastern Parkway 2310
Louisville, Kentucky, 40217
DS RESEARCH, 3810 Springhurst Blvd
Louisville, Kentucky, 40241
DS RESEARCH, 2241 Green Valley Road
New Albany, Indiana, 47150
CENTRAL SOONER RESEARCH, 900 North Porter
Norman, Oklahoma, 73071
DERMATOLOGY SPECIALISTS, INC, 3629 Vista Way
Oceanside, California, 92056
PARISH DERMATOLOGY, INC, 1845 Walnut Street
Philadelphia, Pennsylvania, 19103
THE INDIANA CLINICAL TRIALS CENTER, 824 Edwards Drive
Plainfield, Indiana, 46168
ACTIVMED PRACTICES AND RESEARCH, INC, 110 Corporate Drive
Portsmouth, New Hampshire, 03801
WAKE RESEARCH ASSOCIATES LLC, 3100 Duraleigh Road
Raleigh, North Carolina, 27612
INTEGRATED RESEARCH GROUP, INC, 4646 Brockton Avenue
Riverside, California, 92506
CLINICAL TRIALS OF TEXAS, INC, 7940 Floyd Curl Drive
San Antonio, Texas, 78229
DERMATOLOGY CLINICAL RESEARCH CENTER OF SAN ANTONIO, 7810 Louis Pasteur
San Antonio, Texas, 78229
SAN LUIS DERMATOLOGY AND LASER CLINIC, 15 Santa Rosa Street
San Luis Obispo, California, 93405
WASHINGTON UNIVERSITY - DERMATOLOGY, 4921 Parkview Place
St Louis, Missouri, 63110
WASHINGTON UNIVERSITY - DERMATOLOGY, 969 Mason Road
St Louis, Missouri, 63141
NEW ENGLAND RESEARCH ASSOCIATES LLC, 5520 Park Avenue
Trumbull, Connecticut, 06611
PEAK RESEARCH LLC, 2589 Washington Rd
Upper Saint Clair, Pennsylvania, 15241
CENTER FOR CLINICAL STUDIES, 451 North Texas Avenue
Webster, Texas, 77598
Canada17 sites
CCA MEDICAL RESEARCH, 95 Bayly Street West
Ajax, Ontario, L1S 7K8
SIMCODERM MEDICAL AND SURGICAL DERMATOLOGY CENTER, 5 Quarry Ridge Road
Barrie, Ontario, L4M 7G1
INSTITUTE FOR SKIN ADVANCEMENT, 4935 40th Avenue Nw
Calgary, Alberta, T3A 2N1
LYNDERM RESEARCH INC, 25 Main Street Markham North
Markham, Ontario, L3P 1X2
DERMEDGE RESEARCH INC., 333 Lakeshore Road West
Mississauga, Ontario, L5H 1G9
NORTH BAY DERMATOLOGY CENTRE, 500 Cassells Street
North Bay, Ontario, P1B 3Z7
RESEARCH BY ICLS, 1344 Cornwall Road
Oakville, Ontario, L6J 7W5
OFFICE OF DR. MICHAEL ROBERN, 1 Centrepointe Drive
Ottawa, Ontario, K2G 6E2
SKIN CENTRE FOR DERMATOLOGY, 775 Monaghan Road
Peterborough, Ontario, K9J 5K2
YORK DERMATOLOGY CENTER, 250 Harding Blvd West
Richmond Hill, Ontario, L4C 9M7
CLINIQUE DERMATOLOGIQUE DE SAINT-JEROME, 555 Boul. Saint-antoine
Saint-Jérôme, Quebec, J7Z 3B8
DR. CHIH-HO HONG MEDICAL INC., 15300 105 Avenue
Surrey, British Columbia, V3R 6A7
RESEARCH TORONTO, 208 Bloor Street West
Toronto, Ontario, M5Sz 2B4
K. PAPP CLINICAL RESEARCH, 135 Union Street East
Waterloo, Ontario, N2J 1C4
XLR8 MEDICAL RESEARCH, 2425 Tecumseh Road East
Windsor, Ontario, N8W 1E6
WINDSOR CLINICAL RESEARCH INC, 2224 Walker Road
Windsor, Ontario, N8W 5L7
WISEMAN DERMATOLOGY RESEARCH INC, 6 - 1170 Taylor Avenue
Winnipeg, Manitoba, R3M 3Z4
About this study
Official title: A Phase 2, Randomized, Dose-Ranging, Vehicle-Controlled and Triamcinolone 0.1% Cream-Controlled Study to Evaluate the Safety and Efficacy of INCB018424 Phosphate Cream Applied Topically to Adults With Atopic Dermatitis
The purpose of this study is to establish the efficacy of each strength of ruxolitinib cream once daily (QD) or twice daily (BID) in participants with atopic dermatitis as compared with vehicle cream BID.
- Conditions
- Atopic Dermatitis
- Being tested
- Ruxolitinib 0.15% Cream QD, Ruxolitinib 0.5% Cream QD, Ruxolitinib 1.5% Cream QD, Ruxolitinib 1.5% Cream BID, Triamcinolone 0.1% Cream BID
- Keywords
- Atopic dermatitis, eczema, pruritus, Janus kinase (JAK) inhibitors
- Medical subject headings
- Dermatitis, Atopic, Eczema, Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ruxolitinib 0.15% Cream QDDrug
Also called INCB018424
Ruxolitinib 0.15% cream QD
Ruxolitinib 0.5% Cream QDDrug
Also called INCB018424
Ruxolitinib 0.5% cream QD
Ruxolitinib 1.5% Cream QDDrug
Also called INCB018424
Ruxolitinib 1.5% cream QD
Ruxolitinib 1.5% Cream BIDDrug
Also called INCB018424
Ruxolitinib 1.5% cream BID
Triamcinolone 0.1% Cream BIDDrug
Triamcinolone 0.1% cream BID
Vehicle Cream BIDDrug
Vehicle cream BID
| Study group | Role | What they receive |
|---|---|---|
| Double Blind (DB): Vehicle BID | Placebo comparator | Participants applied vehicle cream twice daily (BID) for 8 weeks DB period. Receives: Drug: Vehicle Cream BID |
| DB: Triamcinolone (TAC) 0.1% BID/Vehicle Cream BID | Active comparator | Participants applied triamcinolone 0.1% cream BID for 4 weeks followed by vehicle cream for 4 weeks in DB period. Receives: Drug: Triamcinolone 0.1% Cream BID; Drug: Vehicle Cream BID |
| DB: Ruxolitinib 0.15% Once Daily (QD) | Experimental | Participants applied ruxolitinib 0.15% cream QD for 8 weeks in DB period. Receives: Drug: Ruxolitinib 0.15% Cream QD |
| DB: Ruxolitinib 0.5% QD | Experimental | Participants applied ruxolitinib 0.5% cream QD for 8 weeks in DB period. Receives: Drug: Ruxolitinib 0.5% Cream QD |
| DB: Ruxolitinib 1.5% QD | Experimental | Participants applied ruxolitinib 1.5% cream QD for 8 weeks in DB period. Receives: Drug: Ruxolitinib 1.5% Cream QD |
| DB: Ruxolitinib 1.5% BID | Experimental | Participants applied ruxolitinib 1.5% cream BID for 8 weeks in DB period. Receives: Drug: Ruxolitinib 1.5% Cream BID |
| Open-Label (OL): Vehicle BID to Ruxolitinib 1.5% BID | Placebo comparator | Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks. Receives: Drug: Ruxolitinib 1.5% Cream BID |
| OL: TAC BID/Vehicle BID to Ruxolitinib 1.5% BID | Active comparator | Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks. Receives: Drug: Ruxolitinib 1.5% Cream BID |
| OL: Ruxolitinib 0.15% QD to Ruxolitinib 1.5% BID | Experimental | Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks. Receives: Drug: Ruxolitinib 1.5% Cream BID |
| OL: Ruxolitinib 0.5% QD to Ruxolitinib 1.5% BID | Experimental | Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks. Receives: Drug: Ruxolitinib 1.5% Cream BID |
| OL: Ruxolitinib 1.5% QD to Ruxolitinib 1.5% BID | Experimental | Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks. Receives: Drug: Ruxolitinib 1.5% Cream BID |
| OL: Ruxolitinib 1.5% BID to Ruxolitinib 1.5% BID | Experimental | Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks. Receives: Drug: Ruxolitinib 1.5% Cream BID |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Percentage Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 4 in Participants Treated With Ruxolitinib 1.5% Cream Twice a Day (BID) Compared With Participants Treated With Vehicle Cream BID
EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.
Measured: Baseline and Week 4
Secondary outcomes (9)
Mean Percentage Change From Baseline in EASI Score at Week 4 in Participants Treated With Ruxolitinib QD Compared With Participants Treated With Vehicle Cream BID
EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.
Measured: Baseline and Week 4
Mean Percentage Change From Baseline in EASI Score at Week 4 in Participants Treated With Ruxolitinib QD/BID Cream Compared With Participants Treated With Triamcinolone 0.1% Cream BID Followed by Vehicle
EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.
Measured: Baseline and Week 4
Mean Percentage Change From Baseline in EASI Score at Week 2 and Week 8
EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.
Measured: Baseline, Week 2 and 8
Percentage of Participants Who Achieve a ≥ 50% Improvement From Baseline in EASI (EASI-50) at Weeks 2, 4, and 8
The categorical variable EASI-50 will be equal to 1 for percentage improvement from baseline in EASI score of 50% or greater and will be equal to 0 for percentage improvement of less than 50%. This definition is introduced for the purpose of identifying participants who respond to the treatment (1 = responder, 0 = non-responder).
Measured: Week 2, 4 and 8
Percentage Change From Baseline in EASI Score at Week 4
EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.
Measured: Baseline and Week 4
Time to Achieve EASI-50
Time to EASI-50 is defined as the interval between the time of randomization and the time of achieving at least 50% improvement in EASI score.
Measured: From Baseline to Week 8
Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of 0 to 1 Who Have an Improvement of ≥ 2 Points From Baseline at Weeks 2, 4, and 8
IGA is an assessment scale used to determine severity of atopic dermatitis (AD) and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response was an IGA score of 0 (clear) or 1 (almost clear). An IGA responder was defined as a participant achieving an IGA score of 0 to 1 and an IGA score improvement at least 2 from baseline.
Measured: Week 2, 4 and 8
Mean Change From Baseline in the Itch Numerical Rating Scale (NRS) Score at Weeks 2, 4, and 8
The Itch NRS is a once-per-24 hours ("daily") participant-reported measure of itch intensity to rate the itching severity because of their AD by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best describes their worst level of itching in the past 24 hours. The categorical NRS is defined as 0 = None, 1 to 3 = Mild, 4 to 6 = Moderate, and 7 to 10 = Severe.
Measured: Baseline, Week 2, 4 and 8
Number of Participants With At Least One Adverse Event (AEs) and as Per Severity
AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurs after a participant provides informed consent. The severity of AEs was assessed using CTCAE v4.03 Grades 1 through 4.Data are reported for Grade 3 and higher severity for this outcome measure.
Measured: Up to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2017 (estimated)
- Study start9 Jan 2017
- Primary completion10 Jan 2018
- Study completion12 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 307 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Kuligowski, MD, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03011892
- Sponsor's protocol ID
- INCB 18424-206
- Status last verified
- Mar 2021
- First submitted
- 3 Jan 2017
- Last updated
- 9 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gong X, Chen X, Kuligowski ME, Liu X, Liu X, Cimino E, McGee R, Yeleswaram S. Pharmacokinetics of Ruxolitinib in Patients with Atopic Dermatitis Treated With Ruxolitinib Cream: Data from Phase II and III Studies. Am J Clin Dermatol. 2021 Jul;22(4):555-566. doi: 10.1007/s40257-021-00610-x. Epub 2021 May 12.
PubMed 33982267Kim BS, Howell MD, Sun K, Papp K, Nasir A, Kuligowski ME; INCB 18424-206 Study Investigators. Treatment of atopic dermatitis with ruxolitinib cream (JAK1/JAK2 inhibitor) or triamcinolone cream. J Allergy Clin Immunol. 2020 Feb;145(2):572-582. doi: 10.1016/j.jaci.2019.08.042. Epub 2019 Oct 17.
PubMed 31629805
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Dose-Ranging, Vehicle-Controlled and Triamcinolone 0.1% Cream-Controlled Study to Evaluate the Safety and Efficacy of INCB018424 Phosphate Cream Applied Topically to Adults With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT03011892
- Acronym / sponsor ID
- INCB 18424-206
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic dermatitis, eczema, pruritus, Janus kinase (JAK) inhibitors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 307 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 9 Jan 2017 (actual)
- Primary completion
- 10 Jan 2018 (actual)
- Study completion
- 12 Mar 2018 (actual)
- First posted
- 5 Jan 2017 (estimated)
- Results
- Posted 9 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to establish the efficacy of each strength of ruxolitinib cream once daily (QD) or twice daily (BID) in participants with atopic dermatitis as compared with vehicle cream BID.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Double Blind (DB): Vehicle BID | Placebo comparator | Drug: Vehicle Cream BIDParticipants applied vehicle cream twice daily (BID) for 8 weeks DB period. |
| DB: Triamcinolone (TAC) 0.1% BID/Vehicle Cream BID | Active comparator | Drug: Triamcinolone 0.1% Cream BID, Drug: Vehicle Cream BIDParticipants applied triamcinolone 0.1% cream BID for 4 weeks followed by vehicle cream for 4 weeks in DB period. |
| DB: Ruxolitinib 0.15% Once Daily (QD) | Experimental | Drug: Ruxolitinib 0.15% Cream QDParticipants applied ruxolitinib 0.15% cream QD for 8 weeks in DB period. |
| DB: Ruxolitinib 0.5% QD | Experimental | Drug: Ruxolitinib 0.5% Cream QDParticipants applied ruxolitinib 0.5% cream QD for 8 weeks in DB period. |
| DB: Ruxolitinib 1.5% QD | Experimental | Drug: Ruxolitinib 1.5% Cream QDParticipants applied ruxolitinib 1.5% cream QD for 8 weeks in DB period. |
| DB: Ruxolitinib 1.5% BID | Experimental | Drug: Ruxolitinib 1.5% Cream BIDParticipants applied ruxolitinib 1.5% cream BID for 8 weeks in DB period. |
| Open-Label (OL): Vehicle BID to Ruxolitinib 1.5% BID | Placebo comparator | Drug: Ruxolitinib 1.5% Cream BIDFollowing DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks. |
| OL: TAC BID/Vehicle BID to Ruxolitinib 1.5% BID | Active comparator | Drug: Ruxolitinib 1.5% Cream BIDFollowing DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks. |
| OL: Ruxolitinib 0.15% QD to Ruxolitinib 1.5% BID | Experimental | Drug: Ruxolitinib 1.5% Cream BIDFollowing DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks. |
| OL: Ruxolitinib 0.5% QD to Ruxolitinib 1.5% BID | Experimental | Drug: Ruxolitinib 1.5% Cream BIDFollowing DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks. |
| OL: Ruxolitinib 1.5% QD to Ruxolitinib 1.5% BID | Experimental | Drug: Ruxolitinib 1.5% Cream BIDFollowing DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks. |
| OL: Ruxolitinib 1.5% BID to Ruxolitinib 1.5% BID | Experimental | Drug: Ruxolitinib 1.5% Cream BIDFollowing DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants diagnosed with atopic dermatitis (AD) as defined by the Hanifin and Rajka criteria.
- Participants with a history of AD for at least 2 years.
- Participants with an Investigator's Global Assessment (IGA) score of 2 to 3 at screening and baseline.
- Participants with body surface area (BSA) of AD involvement, excluding the face and intertriginous areas, of 3% to 20% at screening and baseline.
- Participants who agree to discontinue all agents used to treat AD from screening through the final follow-up visit.
Key exclusion criteria (16 listed)
- Participants with evidence of active acute or chronic infections.
- Use of topical treatments for AD (other than bland emollients) within 2 weeks of baseline.
- Systemic immunosuppressive or immunomodulating drugs (eg, oral or injectable corticosteroids, methotrexate, cyclosporine, mycophenolate mofetil, azathioprine) within 4 weeks or 5 half-lives of baseline (whichever is longer).
- Participants with other dermatologic disease besides AD whose presence or treatments could complicate the assessment of disease (eg, psoriasis).
- Participants with a history of other diseases besides dermatologic disorders (eg, other autoimmune diseases) taking treatments that could complicate assessments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ruxolitinib 0.15% Cream QDAlso: INCB018424Ruxolitinib 0.15% cream QD | Drug | DB: Ruxolitinib 0.15% Once Daily (QD) |
| Ruxolitinib 0.5% Cream QDAlso: INCB018424Ruxolitinib 0.5% cream QD | Drug | DB: Ruxolitinib 0.5% QD |
| Ruxolitinib 1.5% Cream QDAlso: INCB018424Ruxolitinib 1.5% cream QD | Drug | DB: Ruxolitinib 1.5% QD |
| Ruxolitinib 1.5% Cream BIDAlso: INCB018424Ruxolitinib 1.5% cream BID | Drug | DB: Ruxolitinib 1.5% BID, OL: Ruxolitinib 0.15% QD to Ruxolitinib 1.5% BID, OL: Ruxolitinib 0.5% QD to Ruxolitinib 1.5% BID, OL: Ruxolitinib 1.5% BID to Ruxolitinib 1.5% BID, OL: Ruxolitinib 1.5% QD to Ruxolitinib 1.5% BID, OL: TAC BID/Vehicle BID to Ruxolitinib 1.5% BID, Open-Label (OL): Vehicle BID to Ruxolitinib 1.5% BID |
| Triamcinolone 0.1% Cream BIDTriamcinolone 0.1% cream BID | Drug | DB: Triamcinolone (TAC) 0.1% BID/Vehicle Cream BID |
| Vehicle Cream BIDVehicle cream BID | Drug | DB: Triamcinolone (TAC) 0.1% BID/Vehicle Cream BID, Double Blind (DB): Vehicle BID |
Primary outcome
Mean Percentage Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 4 in Participants Treated With Ruxolitinib 1.5% Cream Twice a Day (BID) Compared With Participants Treated With Vehicle Cream BID
Time frame: Baseline and Week 4
EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.
9 secondary outcomes
Mean Percentage Change From Baseline in EASI Score at Week 4 in Participants Treated With Ruxolitinib QD Compared With Participants Treated With Vehicle Cream BID
Time frame: Baseline and Week 4
Mean Percentage Change From Baseline in EASI Score at Week 4 in Participants Treated With Ruxolitinib QD/BID Cream Compared With Participants Treated With Triamcinolone 0.1% Cream BID Followed by Vehicle
Time frame: Baseline and Week 4
Mean Percentage Change From Baseline in EASI Score at Week 2 and Week 8
Time frame: Baseline, Week 2 and 8
Percentage of Participants Who Achieve a ≥ 50% Improvement From Baseline in EASI (EASI-50) at Weeks 2, 4, and 8
Time frame: Week 2, 4 and 8
Percentage Change From Baseline in EASI Score at Week 4
Time frame: Baseline and Week 4
Time to Achieve EASI-50
Time frame: From Baseline to Week 8
Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of 0 to 1 Who Have an Improvement of ≥ 2 Points From Baseline at Weeks 2, 4, and 8
Time frame: Week 2, 4 and 8
Mean Change From Baseline in the Itch Numerical Rating Scale (NRS) Score at Weeks 2, 4, and 8
Time frame: Baseline, Week 2, 4 and 8
Number of Participants With At Least One Adverse Event (AEs) and as Per Severity
Time frame: Up to Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33982267Gong X, Chen X, Kuligowski ME, Liu X, Liu X, Cimino E, McGee R, Yeleswaram S. Pharmacokinetics of Ruxolitinib in Patients with Atopic Dermatitis Treated With Ruxolitinib Cream: Data from Phase II and III Studies. Am J Clin Dermatol. 2021 Jul;22(4):555-566. doi: 10.1007/s40257-021-00610-x. Epub 2021 May 12.
- Derived from this study: PubMed 31629805Kim BS, Howell MD, Sun K, Papp K, Nasir A, Kuligowski ME; INCB 18424-206 Study Investigators. Treatment of atopic dermatitis with ruxolitinib cream (JAK1/JAK2 inhibitor) or triamcinolone cream. J Allergy Clin Immunol. 2020 Feb;145(2):572-582. doi: 10.1016/j.jaci.2019.08.042. Epub 2019 Oct 17.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Kuligowski, MD study director
Incyte Corporation
52 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ruxolitinib 0.15% Cream QD, Ruxolitinib 0.5% Cream QD and Ruxolitinib 1.5% Cream QD in people with Atopic Dermatitis, run by Incyte Corporation at 52 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 52 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Percentage Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 4 in Participants Treated With Ruxolitinib 1.5% Cream Twice a Day (BID) Compared With Participants Treated With Vehicle Cream BID (time frame: Baseline and Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03011892, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2021; AzTrials last refreshed its copy on 8 Nov 2026.